What are regulatory bodies:- In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing. marketing and labeling of pharmaceutical products like: USFDA(USA) MHRA(UK) TGA(Australia AIMS:- Protecting public health through regulation, with acceptablebenefit-risk profiles for medicines and devices. Promoting public health by helping people who use these productsto understand their benefits and risks. Improving public health by encouraging and facilitating developments in products that will benefit people GUIDELINES:- Guidelines for Manufacturers on Clinical Investigations to be carried out in the UK. Inspected UK Contract GMP Quality Control Laboratories. BLUE GUIDE: Advertising and Promotion of medicines in the UK. ORANGE GUIDE: Rules and Guidelines for Pharmaceutical Manufacturers and Distributors. Good Pharmacovigilance Practice Guide. Guidelines on Process Validation Guide to UK GLP Regulations 1999 Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products. Guide to defective medicinal products. Introduction of a Risk Based Inspection Programme for GMP Labs. SALIENT FEATURES, COMMITTEES/WORKING GROUPS:- MHRA has the power to withdraw a product from market and suspend production of medicines. A manufacturer or distributor can be prosecuted if the law has been broken. Regulatory decisions are impartial D Different products are treated differently. MHRA collaborates with : US Food and Drug Administration NPSA National Patient Safety Agency NICE National Institute for Health and Clinical Excellence

1. Medicines and Healthcare products
Regulatory Agency(MHRA)
A
PRESENTATION
OF
MASTER OF PHARMACY
IN
PHARMACEUTICS 1ST SEM
COURSE CODE - MPH104T
COURSE NAME- REGULATORY AFFAIRS
DEPARTMENT OF PHARMACOLOGY
TEERTHANKER MAHAVEER COLLEGE OF PHARMACY
TEERTHANKER MAHAVEER UNIVERSITY
MORADABAD INDIA
SESSION: 2022-2023
SUBMITTED BY
PRAKHAR VARSHNEY

2. What are regulatory bodies
In the present scenario, pharmaceuticals are considered as the most
highly regulated industries worldwide. The regulatory body ensures
compliances in various legal and regulatory aspects of a drug. Every
country has its own regulatory authority, which is responsible to enforce
the rules and regulations and issue the guidelines to regulate drug
development process, licensing, registration, manufacturing. marketing
and labeling of pharmaceutical products like:
USFDA(USA)
MHRA(UK)
TGA(Australia)

3. Countinued……
CDSCO(central drug standard control organisation) – India
 HEALTH CANADA – CANADA
MCC(medicines control council) - South Africa
ANVISA (Agencia national de vigilancia sanitaria) – Brazil
EMEA (European medicines agency) – Europe
KFDA(Korean food and drug administration) - South Korea
MOH (Ministry of health) - Sri Lanka

4. Introduction
The MHRA (1903) is a government agency which is responsible for
ensuring that medicines and medical devices work, and are acceptably
safe.
Medical Control Agency (MCA) + Medical Devices Agency (MDA)=
MHRA
It was located in Vauxhall, London and is now relocated to New
London.

5. AIMS
Protecting public health through regulation, with acceptablebenefit-
risk profiles for medicines and devices.
Promoting public health by helping people who use these productsto
understand their benefits and risks.
 Improving public health by encouraging and facilitating
developments in products that will benefit people.

6. COMPOSITION AND STRUCTURE
The agency board is made up of
Non-Executive Chairman
Six Non-Executive Member
 Agency's Chief ExecutiveThe Agency's Chief Executive is responsible
for service delivery and resources.
 The Executive Board consisting of Agency's Directors.
 The Agency Board is chaired by the MHRA Chairman.

8. AGENCY BOARD
The agency is responsible for:
Ensuring that medicines, medical devices and blood components for
transfusion meet applicable standards of safety, quality and efficacy.
Ensuring that the supply chain for medicines, medical devices and
blood components is safe and secure.
Promoting international standardisation and harmonisation to assure
the effectiveness and safety of biological medicines.
Helping to educate the public and healthcare professionals about the
risks and benefit of medicines, medical devices and blood
components, leading to safer and more effective use.

9. Countinued…
 Supporting innovation and research and development that's beneficial
to public health.
Influencing UK, EU and international regulatory frameworks so that
they are risk-proportionate and effective at protecting public health.

10. SALIENT FEATURES, COMMITTEES/WORKING
GROUPS:
MHRA has the power to withdraw a product from market and suspend
production of medicines.
A manufacturer or distributor can be prosecuted if the law has been
broken.
Regulatory decisions are impartial D Different products are treated
differently.
MHRA collaborates with :
US Food and Drug Administration
NPSA National Patient Safety Agency
 NICE National Institute for Health and Clinical Excellence

11. OTHER FEATURES
LICENSING PROCESS
Application of Clinical trials
Evaluation by MHRA
If satisfied then Clinical Trials
Assessment of Data by Experts
Marketing Authorization

13. SUBMISSION OF APPLICATION
CTD Common technical dossier
e-CTD Electronic Common technical dossier
PDF only format

14. Types of
procedure
Centralized
Decentralized
Mutual
recognition
National

15. RENEWAL OF LICENSE
New Marketing Authorization are valid for 5 years
Renewal is done on the basis of re-evaluation of risk benefit balance
Once renewed, Marketing Authorization will be valid for either 5
years or unlimited period
Application for renewal should be submitted at least 6 months before
expiry

16. CANCELLATION OF LICENSE
 If MA holder does not file an application for renewal within specified
time, MA expires
 If MA holder does not wish to renew the license, a letter should be
sent indicating cancellation
 MHRA has authority to cancel license of product if it affects public
health

17. MHRA
ACTIVITIES
Regulating
Clinical trials
Assessing
safety, quality
and efficasy
Promoting
Good Practice
in the safe use
Inspection and
Enforcement
Action
Overseeing the
notified bodies
that audit the
manufactures
Manufacturing
general
practice
Research
Database

18. WHAT DOES
MHRA
REGULATE??
MEDICINE
NANOTEC
HNOLOGY
BLOOD
DEVICE
ADVANCE
THERAPEU
TICMEDICI
NAL
PRODUCT

19. GUIDELINES
• Guidelines for Manufacturers on Clinical Investigations to be carried out in the UK.
• Inspected UK Contract GMP Quality Control Laboratories.
• BLUE GUIDE: Advertising and Promotion of medicines in the UK.
• ORANGE GUIDE: Rules and Guidelines for Pharmaceutical Manufacturers and
Distributors.
• Good Pharmacovigilance Practice Guide.
• Guidelines on Process Validation
• Guide to UK GLP Regulations 1999
• Recommendations on the control and monitoring of storage and transportation
temperatures of medicinal products.
• Guide to defective medicinal products.
• Introduction of a Risk Based Inspection Programme for GMP Labs.

20. REFERENCE
• https://www.gov.uk/guidance/renew-marketing-authorisation-for-a-human-
medicine£apply-to-renew-your-ma
• https://www.gov.uk/government/organisations/medicines-and- healthcare-
products-regulatory-agency
• https://www.gov.uk/government/news/welcome-to-our-new-mhra- website
• https://in.linkedin.com/showcase/mhra
• https://www.meddra.org/about-meddra/organisation/management-board/uk-
mhra
• https://www.abpi.org.uk/media-centre/news/2018/august/abpi-